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CTRI Number  CTRI/2024/07/071006 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate the efficacy of oral administration of Nimbashatka choorna and Nimba malahara lepa with Vidangadi choorna and Nimba malahara lepa in itching per vagina. 
Scientific Title of Study   A randomized open-labelled comparative clinical study to evaluate the efficacy of oral administration of Nimbashatka choorna and Nimba malahara lepa with Vidangadi choorna and Nimba malahara lepa in Acharana yonivyapat with special reference to pruritus vulvae 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopika P 
Designation  PG scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082

Bangalore
KARNATAKA
560082
India 
Phone  9497707579  
Fax    
Email  pannikotegopika2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rachana HV 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082

Bangalore
KARNATAKA
560082
India 
Phone  9535744077  
Fax    
Email  dr.rachanabhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gopika P 
Designation  PG scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082

Bangalore
KARNATAKA
560082
India 
Phone  9497707579  
Fax    
Email  pannikotegopika2@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital 
 
Primary Sponsor  
Name  Dr Gopika P 
Address  Sri Sri College of Ayurvedic Science and Research, Kanakpura Road, Udayapura P.O,560082 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sri Sri College of Ayurvedic Science and Research  Kanakpura Road, Udayapura P.O,560082 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopika P  Sri Sri College of Ayurvedic science and Research Hospital  Department of Prasuti Tantra and Stree Roga, Room No. 10, Sri Sri College of Ayurvedic science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore - 560082, Karnataka
Bangalore
KARNATAKA 
9497707579

pannikotegopika2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L292||Pruritus vulvae. Ayurveda Condition: ACARANA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: VIDANGADI CHURNA, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: -
(2) Medicine Name: NIMBA MALAHARA LEPA, Reference: KAIYYADEVA NIGHANTU, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: NIMBASHATKA CHURNA, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: -
(2) Medicine Name: NIMBA MALAHARA LEPA, Reference: KAIYYADEVA NIGHANTU, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1)Subjects irrespective of marital status
2) Subjects in perimenopausal and post-menopausal age group
3)Subjects diagnosed with classical symptoms of Acharana yonivyapath
4)Subjects with classical symptoms of Pruritus vulvae.
5)Subjects willing to sign the consent form  
 
ExclusionCriteria 
Details  1.Subjects who are pregnant and lactating mothers.
2.Subjects during the time of menstruation.
3.Subjects with uncontrolled diabetes mellitus.
4.Subject with known case of sexually transmitted diseases.
5.Subject with known case of benign and malignant conditions.
6.Subject with known case of systemic disorders.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
There is significant decrease in Pruritus vulvae which will be assessed based on 5-D Pruritus scale  Pre assessment 0th day
1st assessment On 7th day
Follow up On 15th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in-depth analysis of duration, degree, direction, disability & distribution of Pruritus vulvae
Generation of data on possible unexpected drug reaction.
 
0th day to 15th day
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
      

Throughout history, the central role of women in society has ensured the stability, progress and longterm development of nations. Today, the median female shares of the global workplace is 45.4% wherein the role of women in the urban and rural workforce has expanded exponentially in recent decades . It is, therefore, important to focus on women and their health. In this regard, Ayurveda plays an important role in preserving the comprehensive wellbeing of a woman. And this study aims at targeting one such ailment in Gynaecology. Improper hygiene (Adhavana) of yoni leads to the formation of Jantu which in turn leads to excessive itching in the Yoni  and this condition is termed as Acharana Yonivyapath. A similar entity in modern classics, where there is excessive itching in the vulvar region is termed as Pruritus Vulvae. Pruritus Vulvae is a symptom which is experienced by not less than 10% of women attending gynecological clinics. If not treated properly, profound itching in Vulval Pruritus leads to uncontrollable scratching, which results in conditions like Lichen simplex chronicus, now called Hyperplastic vulval dystrophy. Many modern medications like anti-fungal, antibacterial, corticosteroids, local anaesthetic agents have been in use for this condition. But they have their own side effects. In Ayurvedic classics, there are many references to treat Kandu. Among them, oral administration of Nimbashatka choorna and Vidangadi choorna  is said to be effective in Pruritus Vulvae. Nimbashatka choorna contains Nimba, Kutaja, Saindhava, Hingu, Vidanga and Ramata and Vidangadi choorna with ingredients Vidanga, Triphala and Krishna are indicated in Kustha, Krimi, Meha, Nadi vrana and Bhagandara. Both the Choornas are selected for the study because of their Krimighna and Kandughna property. Nimba Malahara lepa is a topical application of medicated ointment where in the duration of drug application is more compared to lepa. Nimba being Krimihara, Kaphahara and Kandughna is the best drug of choice for Lepana. External application of Nimba added with the oral medicines facilitates easier as well as faster recovery from the symptoms. This study therefore, intends to aid diagnosis and rationalize prescribing, to find a sure shot treatment for Acharana Yonivyapath.

 
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